Validation of LIMS is a part of the data integrity

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Lead Consultant, Segalstad Consulting AS
    Biography
      Siri H. Segalstad has worked with validation of IT systems in the pharmaceutical and other regulated industries since 1988. She has worked with accredited laboratories and knows the ISO 17025 standard very well. She was approved as an auditor for Norwegian Accreditation in 1998. She has also written the book "International IT Regulations and Compliance", Wiley 2008 which covers all aspects of IT regulations and validation. She is the lead consultant in Segalstad Consulting AS, Norway. She has been teaching this in classes at Pittcon, Dubai and other places for many years with good feedbacks from the participants.

    Abstract

    LIMS systems are used extensively in laboratories everywhere. As a tool in the lab we need to be able to trust the system to have the necessary data integrity. Just like the analytical methods, also the tool LIMS must be validated. Otherwise: How can you trust the system? Validation of tools like LIMS is a part of all lab standards; the GxP and ISO 17025 to mention a couple. This short presentation will cover the approach to validation of LIMS. The same approach can be used for all other IT systems including the instrument systems in the lab. Tools in the process are also mentioned.

    Learning Objectives:

    1. Approach to validation and which tools to use

    2. Content of the validation plan and its parts, including how to create test plans and document the testing

    3. On-going validation


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